Thoughts on our circumstances...: Remember this corporate leach?

Saturday, June 15, 2024

Remember this corporate leach?

Editor's note: So, Donald Trump, why did you pick Gottlieb to head the FDA when we were attacked with the global Covid assault? Just in case people did not no this, nicotine does not cause cancer. The FDA wants all nicotine products removed from the market because nicotine is a critical component in the bodies response to Covid. Every cell in the body has nicotine receptors including in the gut. A few people, when chewing and swallowing nicotine gum get nauseous and vomit or get loose stools. This is because so much of the venom (Covid injection ingredients) in spike proteins are attached to the nicotine receptors that line your entire bowel lining, and when nicotine is present, the massive amount of venom in the bowel lining gets released and you will feel like you have food poisoning. Now people know why Gottlieb is a prototypical corporate leach.

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Reminder: there are no requirements for FDA inspections of biologics facilities

This affects ALL biologics, not just EUA Countermeasures which do not have to comply with cGMP laws anyway

By Sasha Latypova | June 15, 2024

Scott Gottlieb is a prototypical corrupt leach, shuttling between government and corporate feeders. He was the 23rd commissioner of the Food and Drug Administration (FDA) from May 2017 until April 2019. He is presently a senior fellow at the [obviously fake-] conservative think tank the American Enterprise Institute (AEI), a partner at the venture capital firm New Enterprise Associates (NEA), a member of the board of directors of drug maker Pfizer, Inc and gene sequencing company Illumina, Inc., and a contributor to the cable financial news network CNBC and the CBS News program Face the Nation. Yada, yada, you get the idea…

Among other things not mentioned on his Wikipedia page, he is affiliated with the CIA-backed biomanufacturing company - Resilience and he personally profits from deploying bio-chemical poisoning agents on people worldwide.

Here is a good review of Resilience (aka Nanotherapeutics, aka Ology and a few other names). Click on the link:

DIG: The CIA has deep ties to the manufacture of Moderna’s COVID vaccine as reported by @_whitneywebb and @dezzie_rezzie

This video ain’t going on TikTok 🤷‍♂️ https://t.co/pu5l1ciIjU pic.twitter.com/8KUXXk1tPf
— Ian Carroll (@Cancelcloco) December 14, 2023

I would like to highlight this post by Katherine Watt explaining the rule change for manufacturing facilities inspections that was made by Scott Gottlieb while FDA Commissioner, before departing for greener pastures being the board member of bio-manufacturing facilities.

Bailiwick News:

Legalized FDA non-regulation of biological products effective May 2, 2019, by Federal Register Final Rule, signed by then-FDA Commissioner Scott Gottlieb.

Until May 2, 2019, FDA inspectors were required to inspect all establishments or facilities producing biological products at least once every two years, and held eight enumerated inspection duties.

Since May 2, 2019, FDA inspectors have had none of those duties, and are not required to inspect biological product manufacturing facilities at any time intervals.

Prior to the rule change, 21 CFR 600.21, Time of inspection, read:

The inspection of an establishment for which a biologics license application is pending need not be made until the establishment is in operation and is manufacturing the complete product for which a biologics license is desired.

In case the license is denied following inspection for the original license, no reinspection need be made until assurance has been received that the faulty conditions which were the basis of the denial have been corrected. An inspection of each licensed establishment and its additional location(s) shall be made at least once every 2 years. Inspections may be made with or without notice, and shall be made during regular business hours unless otherwise directed.

Effective May 2, 2019, the last three sentences of 21 CFR 600.21 were removed.

There is currently no legal requirement for an initial FDA inspection; no minimum interval for subsequent FDA inspections, and there are no legal consequences for compliance failures, such as establishment or product license denial or revocation.

I would like to emphasize that this change was made by Scott Gottlieb, who holds financial interests in several large biologics manufacturers and genetic sequencing equipment companies.

This explains why the FDA has not audited Pfizer and Moderna prior to large scale commercial deployment of Poison-19 “vaccines”. At the time, in late 2020 to 2021 they claimed it was dangerous to send inspectors out due to covid. I find this lie curious: they could have just pointed to the rule change made by Gottlieb in 2019, but they didn’t. They needed the excuse of “covid” to misrepresent the true state of things to the public and to professionals. They needed the Potemkin village of “quality biopharmaceutical manufacturing”. Later in 2022 some of the inspections were done at suppliers - all found non cGMP compliant. Zero enforcement action resulted from these findings. Finally, in September 2023 Moderna was inspected and failed to demonstrate cGMP compliance. No enforcement actions have been brought by the FDA, and none are expected, since it is legal to ship adulterated and misbranded EUA Countermeasures.

Please go to substack to continue reading.

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